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Prediction of Outcome in Severe Preeclampsia

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT03871764
Recruitment Status : Completed
First Posted : March 12, 2019
Last Update Posted : March 12, 2019
Information provided by (Responsible Party):
Olfat Nooh Riad Ali, Cairo University

Brief Summary:
this summary studied the predictive values of factor V Leiden mutation , doppler indices , placental pathology to unfavorable fetal and maternal outcomes

Condition or disease Intervention/treatment
Leiden Factor V Deficiency,Preeclampsia Doppler Examination Palental Pathology Diagnostic Test: blood sample , doppler of uterine vessel and placenta

Detailed Description:
leiden mutation is activated protein C resistance with hypercoagulable states and increased thrombotic risk. 99 % are heterozygous and 1 % is homozygous , very rare cases are psoudohomozygous with factor V deficiency. relation to this mutation was studied in severe preeclamptic patients. doppler indices of uterine arteries , increased pulsetility index or unilateral or bilateral uterine artery notch and placental pathology were studied.

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Study Type : Observational [Patient Registry]
Actual Enrollment : 100 participants
Observational Model: Case-Only
Time Perspective: Cross-Sectional
Target Follow-Up Duration: 7 Days
Official Title: Relation of 3rd Trimester Uterine Artery Doppler Flow Velocimetry Indices, Factor V Leiden Mutation and Placental Pathology to the Severity of Preeclampsia
Actual Study Start Date : December 1, 2015
Actual Primary Completion Date : September 30, 2016
Actual Study Completion Date : April 2017

Intervention Details:
  • Diagnostic Test: blood sample , doppler of uterine vessel and placenta
    blood sample for factor V and doppler examination of uterine arteries , placenta pathology post partum

Primary Outcome Measures :
  1. percentage of patients develop abruption placenta, intrauterine growth retardation or delivered premature [ Time Frame: within 12 wks from diagnosis of severe preeclampsia ]
    placental abruption, prematurity, IUGR

  2. percentage of fetuses and neonates complicated with intrauterine fetal death or need admission to incubator [ Time Frame: from diagnosis of severe preeclampsia till one week after delivery ]
    IUFD, admission to neonatal IUC

Biospecimen Retention:   Samples Without DNA
blood samples and placental pathology

Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Pregnant women with preeclampsia in 3rd trimester. Singleton pregnancy. Accurate gestational age confirmed by last menstrual period or sonography before 20 weeks.

Inclusion Criteria: severe preeclampsia in 3rd trimester -

Exclusion Criteria:Twin pregnancy. Fetal congenital anomalies. Diabetic patient, impaired renal function. Any medical disorders even that HTN. Any placental pathology,Autoimmune diseases. Women with uterine activity or clinical emergencies with maternal hemodynamic instability or an indication for immediate termination of pregnancy.


Additional Information:

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Responsible Party: Olfat Nooh Riad Ali, professor, Cairo University Identifier: NCT03871764     History of Changes
Other Study ID Numbers: 019002
First Posted: March 12, 2019    Key Record Dates
Last Update Posted: March 12, 2019
Last Verified: March 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Factor V Deficiency
Hypertension, Pregnancy-Induced
Pregnancy Complications
Blood Coagulation Disorders, Inherited
Blood Coagulation Disorders
Hematologic Diseases
Coagulation Protein Disorders
Hemorrhagic Disorders
Genetic Diseases, Inborn